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Easy Diabetes Treatment Study 1 (EASY-1)

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ClinicalTrials.gov Identifier: NCT03258268
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborators:
Region Skane
Lund University
Information provided by (Responsible Party):
Läkarexpressen AB

Brief Summary:
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Standard of Care with EASY DSS Other: Standard of Care without EASY DSS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized controlled trial
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.
Primary Purpose: Treatment
Official Title: A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : September 7, 2018
Estimated Study Completion Date : October 7, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Standard of Care with DSS

Patients will receive standard of care with a board certified physician with EASY DSS.

The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.

Device: Standard of Care with EASY DSS

The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients.

Patients will receive standard of care with a board certified physician with EASY DSS.

The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.

Active Comparator: Standard of Care without DSS

Patients will receive standard of care with a board certified physician without EASY DSS.

The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.

Other: Standard of Care without EASY DSS

Patients will receive standard of care with a board certified physician without EASY DSS.

The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 26 weeks ]
    Change from baseline HbA1c


Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 26 weeks ]
    Change from baseline in fasting plasma glucose (FPG)

  2. Achieving treatment target [ Time Frame: 26 weeks ]
    Meeting treatment target of HbA1c < 7% (53 mmol/mol)

  3. Hypoglycemia [ Time Frame: 26 weeks ]
    Meeting treatment target of HbA1c < 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • ≥ 18 years of age at the time of signing informed consent
  • Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
  • HbA1c 7.5 - 10.0% [58 mmol/mol - 86 mmol/mol] (both inclusive) by central laboratory analysis
  • Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)

Exclusion Criteria:

  • Previous participation in this trial. Participation is defined as informed consent.
  • Currently participating in other clinical trials for diabetes
  • Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
  • History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
  • Corticosteroid-induced or pancreatitis-induced diabetes
  • History of chronic or acute pancreatitis
  • Known or suspected substance abuse
  • Pregnancy
  • Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins)
  • Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 95 mmHg)
  • Impaired liver function, defined as alanine aminotransferase (ALAT) ≥ 2.5 times upper normal range (UNR)
  • Impaired renal function defined as serum-creatinine ≥ 133 μmol/L (≥ 1.5 mg/dL) for males and ≥ 125 μmol/L (≥ 1.4 mg/dL) for females or as defined according to local contraindications for metformin
  • Recent or planned major surgery (such as gastric bypass operation)
  • Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel
  • Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258268


Contacts
Contact: Damon Tojjar, MD 0709662513 damon.tojjar@med.lu.se

Locations
Sweden
Region Skåne Recruiting
Skåne, Sweden
Contact: Ulf Malmqvist, MD       Ulf.Malmqvist@skane.se   
Sponsors and Collaborators
Läkarexpressen AB
Region Skane
Lund University
Investigators
Principal Investigator: Damon Tojjar, MD Lund University

Responsible Party: Läkarexpressen AB
ClinicalTrials.gov Identifier: NCT03258268     History of Changes
Other Study ID Numbers: EASY-1
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases